QVA149 improves lung function and reduces exacerbations compared to tiotropium in patients with severe-to-very severe COPD: The SPARK study

TLDR: In this article, the effect of a dual bronchodilator fixed-dose combination of indacaterol and glycopyrronium (GLY) on lung function and exacerbation rates in comparison with TIO was evaluated.

Abstract: Introduction Sustained bronchodilation is thought to contribute to the reduction in exacerbations in patients with COPD. Here we evaluate the effect of once-daily QVA149, a dual bronchodilator fixed-dose combination of indacaterol and glycopyrronium (GLY), on lung function and exacerbation rates in comparison with tiotropium (TIO). Methods Patients aged ≥40 yrs with severe-to-very severe COPD were randomized to receive double-blind QVA149 110/50 μg or GLY 50 μg, or open-label TIO 18 μg. The treatment period was 64 weeks followed by a variable exposure up to 76 weeks. Post-dose forced expiratory volume in 1 s (FEV1) at 30 min and 1 h post-dose at weeks 1, 4, 12, 26, 38, 52, 64, and 76 and exacerbation rates were analyzed. Results Of the patients randomized to QVA149 (n=741) and TIO (n=742), 77% and 75% patients completed the study, respectively. The least squares (LS) mean treatment difference of post-dose FEV1 significantly favored QVA149 over TIO at all visits (p<0.001). The LS mean range of improvement over the entire 76 weeks is presented in the table. Improvements in lung function translated to lower exacerbation rate with QVA149 versus TIO (Rate Ratio 0.86; 95% CI 0.78–0.94; p<0.01). View this table: Table: Range in post dose FEV1 (L) Conclusions Superior improvements in lung function with QVA149 resulted in a significant reduction in exacerbations compared with tiotropium over 76 weeks in patients with severe-to-very severe COPD.